DESCRIPTION: Prostate Cancer: Family Care for Patients and Spouses Prostate
cancer is the most common cancer among men in the United States. Treatments for
prostate cancer are often accompanied by devastating complications such as
sexual impotence, urinary incontinence, and bowel dysfunction that can severely
affect the quality of life of men and their spouses. The purpose of this study
is to determine if a family-based intervention (The FOCUS Program) can improve
the long-term quality of life of men with prostate cancer and their spouses.
There are two specific aims for this study. The first aim is to determine if
the family-based intervention can improve proximal clinical outcomes (better
family communication, higher self-efficacy, more problem-focused coping, and
less threat, uncertainty, and hopelessness) and improve the distal clinical
outcome, better quality of life, in a culturally and socioeconomically diverse
sample of men with prostate cancer and their spouses. The second aim is to test
a stress-coping model designed to predict which prostate cancer patients and
their spouses are at increased risk of poorer long-term quality of life. The
model includes antecedent, mediating, and outcome variables. The specific aims
will be accomplished with a longitudinal, randomized-block clinical trial in
which a cohort of men with prostate cancer and their spouses (N=222 dyads) will
be followed over a 12 month period of time. Dyads will be stratified by three
phases of illness: 1) newly diagnosed-localized phase, following prostatectomy
or radiation therapy, 2) post-primary treatment phase with rising PSA
(biochemical recurrence), and 3) advanced/metastatic phase with evidence of
disease progression; and by type of treatment received. Following
stratification, dyads will be randomized to the control (standard care) or
experimental group (standard care plus FOCUS Program). The FOCUS Program is
administered in three face-to-face home visits and two follow-up phone calls
and provides core content in five areas: Family involvement, Optimistic
attitude, Coping effectiveness, Uncertainty reduction, and Symptom management.
The program also has tailored content related to phase of illness and treatment
received. Data will be collected four times: baseline, prior to the
intervention (Time 1); 4 months, shortly after the completion of the
intervention (Time 2); 8 months (Time 3); and 12 months (Time 4) with a set of
established standardized instruments. The main analysis to meet Aim 1(test of
the intervention) will be the MANOVA approach to repeated measures ANOVA
(intervention x time), and the main analysis for Aim 2 will use manifest
variable structural equation modeling. Overall, this study will test the
effectiveness of a family-based program of care in improving clinical outcomes,
and test the ability of a model to predict which patients and spouses are at
increased risk of poorer quality of life.